Disposable hand-held device for collection of exhaled breath condensate

• US 20070203424A1
• Filed: 05/01/2007
• Published: 08/30/2007
• Est. Priority Date: 12/20/2002
• Status: Active Grant

• Current Assignee: Charlotte Mecklenburg Hospital Authority
• Original Assignee: Charlotte Mecklenburg Hospital Authority
• Inventors: Kline, Jeffrey
• Granted Patent: US 8,491,494 B2
• Time in Patent Office: Days
• US Class Current: 600/543
• CPC Class Codes: A61B 2010/0087 Breath samples
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices

Abstract

A breath condensate collection apparatus comprising a central chamber, a breath input assembly, a plunger assembly and a breath condensate collection port. The central chamber has inner and outer side walls with a coolant material sealed in between. The breath input assembly is disposed on the side of the central chamber in fluid communication with the chamber interior. The plunger assembly has a piston, slidably disposed in the chamber, and a handle extending from a first end of the chamber. The collection port is disposed at the second end of the central chamber in fluid communication with the interior of the chamber. Obstructive structures may be arranged in the chamber interior for increasing the surface area on which condensate may form. The apparatus may also include an outlet assembly that may be removed and replaced with a sampling well into which the condensate may be washed with a buffer solution.

Claims

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16. A method of collecting breath condensate, the method comprising:

providing a central chamber having double side walls, first and second opposing ends, a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber, and a breath condensate collection port disposed at the second end of the central chamber;

lowering the temperature of the coolant material to chill at least the inner walls of the central chamber;

receiving, in the interior of the central chamber, exhaled breath from a patient, delivered through the inner and outer side walls via a breath input assembly disposed on the outside of the outer side wall of the central chamber;

condensing portions of the exhaled breath on the inner surfaces of the inner walls of the central chamber;

expressing condensate, produced during the condensing step, from the central chamber by depressing a plunger assembly through the central chamber, thereby forcing the condensate into the breath condensate collection port; and

aspirating the expressed condensate from the breath condensate collection port for analysis thereof.

17. The method of claim 16, wherein the aspirating step includes aspirating the expressed condensate into a pipette, the method further comprising:

transferring the condensate from the pipette to a separate assay well for analysis thereof.

18. The method of claim 17, wherein providing a central chamber includes providing a central chamber having an outlet and outlet valve disposed on the top of the outer side wall of the central chamber adjacent the second end thereof and the breath condensate collection port disposed on the bottom of the central chamber, the method further comprising:

temporarily sealing the breath condensate collection port during the receiving and condensing steps.

19. The method of claim 17, wherein providing a central chamber includes providing a central chamber having at least one clip mounted at the first end of the central chamber, the method further comprising:

after expressing the condensate by depressing the plunger assembly, locking, via the at least one clip, the handle of the plunger assembly in a fully depressed position to facilitate transport or handling of the breath condensate collection apparatus until aspirating the expressed condensate.

20. The method of claim 17, wherein receiving exhaled breath includes receiving the exhaled breath delivered through the inner and outer side walls via a breath input assembly disposed underneath the central chamber.

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31. A method of collecting breath condensate, the method comprising:

providing a double-walled central chamber having one or more obstructive structures arranged in the interior thereof and a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;

lowering the temperature of the coolant material to chill at least the inner walls of the central chamber and the obstructive structures;

receiving, in the interior of the central chamber, exhaled breath from a patient;

condensing portions of the exhaled breath on the inner surfaces of the inner walls of the central chamber and on the obstructive structures; and

removing condensate, produced during the condensing step, from the central chamber.

32. The method of claim 31, wherein the removing step includes washing the condensate from the obstructive structures.

33. The method of claim 32, wherein the washing step includes adding an amount of liquid to the central chamber, wherein the amount is selected to correspond to the amount of condensate present in the central chamber.

34. The method of claim 32, wherein the washing step includes adding an amount of liquid to the central chamber, wherein the amount is selected to correspond to the amount of condensate likely to be present in the central chamber after the patient exhales into the central chamber for a predetermined period of time.

35. The method of claim 32, wherein the washing step includes adding an amount of liquid to the central chamber, wherein the amount is selected to correspond to the amount of condensate likely to be present in the central chamber after the patient completes a predetermined number of exhalations into the central chamber.

36. The method of claim 32, further comprising the step of removing the obstructive structures from the central chamber before carrying out the washing step.

37. A method of collecting breath condensate, the method comprising:

providing a double-walled central chamber having a removable outlet assembly and a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;

lowering the temperature of the coolant material to chill at least the inner walls of the central chamber;

receiving, in the interior of the central chamber, exhaled breath from a patient;

condensing portions of the exhaled breath on the inner surfaces of the inner walls of the central chamber;

removing the outlet assembly and replacing it with a sampling well; and

moving condensate, produced during the condensing step, from the central chamber to the sampling well.

38. The method of claim 37, wherein the step of moving condensate includes washing condensate from the central chamber into the sampling well with a known liquid.

39. The method of claim 38, wherein the step of washing condensate includes:

introducing a predetermined quantity of the known liquid into the central chamber;

mixing the predetermined quantity of the known liquid with the condensate; and

draining the known liquid and the condensate from the central chamber into the sampling well.

40. The method of claim 39, wherein the step of removing the outlet assembly includes creating an opening into the central chamber, and wherein the step of introducing includes introducing the known liquid through the opening.

41. The method of claim 39, further comprising:

before replacing the outlet assembly with the sampling well, storing the known liquid in the sampling well.

42. The method of claim 38, wherein the known liquid is a buffer solution.

43. The method of claim 42, wherein the buffer solution is distilled water.

44. The method of claim 42, wherein the buffer solution includes an organic dye to indicate the pH of the solution.

45. The method of claim 38, further comprising:

before replacing the outlet assembly with the sampling well, storing the known liquid in the sampling well.

46. The method of claim 38, further comprising:

before replacing the outlet assembly with the sampling well, storing the known liquid in the sampling well.

47. A method of collecting breath condensate, the method comprising:

providing a double-walled central chamber having one or more obstructive structures arranged in the interior thereof and a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;

calibrating the walls and coolant material of the double-walled central chamber such that, when beginning at a predetermined temperature, a chosen number of breaths, received from a typical patient, creates a sufficient amount of breath condensate to be collected on the inner surfaces of the inner walls of the central chamber;

lowering the temperature of the coolant material to the predetermined temperature to chill at least the inner walls of the central chamber;

receiving, in the interior of the central chamber, a plurality of exhalations from a particular patient, wherein the number of exhalations is within a predetermined range established on the basis of the chosen number of breaths;

condensing portions of the exhalations, received from the patient, on the inner surfaces of the inner walls of the central chamber; and

removing condensate, produced during the condensing step, from the central chamber.

48. The method of claim 47, wherein the predetermined range is 10 to 25 breaths, inclusive.

49. The method of claim 47, wherein the predetermined temperature is the temperature of a standard freezer.

50. The method of claim 49, wherein the predetermined temperature is 0°

F.